a trial of shr-2002 injection or combined with other anti-cancer medication in advanced malignant tumors of patients

Conditions: Advanced Malignant Tumors

Summary: the study is being conducted to evaluate safety, tolerability, pharmacokinetics and preliminary efficacy of shr-2002 injection monotherapy and in combination with other anti-cancer therapy for advanced malignant tumors of patients. to explore the reasonable dosage of shr-2002 injection monotherapy and dosage regimen of combination therapy for advanced malignant tumors of patients.


Eligibility criteria:
inclusion criteria: 1. ability to understand and voluntarily agrees to participate by giving written informed consent for the study; 2. male or female aged ≥18 years and ≤70 years at the time of signing the icf; 3. histopathologically or cytologically documented advanced or metastatic malignancies; 4. an eastern cooperative oncology group (ecog) performance status (ps) score of 0 or 1; 5. life expectancy ≥12 weeks; 6. adequate organ functions as defined; 7. female and male patients of reproductive potential must agree to use highly effective contraception during the study treatment period and within 6 months after the last investigational drug administration; female of childbearing potential must have a negative serum human chorionic gonadotropin (hcg) test within 7 days before the first dose of the investigational drugs and must not be breastfeeding. exclusion criteria: 1. patients with known active central nervous system (cns) metastases and/or carcinomatous meningitis; 2. patients with active brain metastasis (without medical control or with clinical symptoms), cancerous meningitis, spinal cord compression, or patients with a history of primary tumors of the central nervous system ; 3. patients with tumor-related pain that cannot be controlled as determined by the investigator; 4. uncontrollable third-space effusion, such as pleural effusion, pericardial effusion or peritoneal effusion; 5. systemic anti-tumor therapy within 28 days prior to the first dose of the study treatment; 6. surgical procedures requiring general anesthesia within 28 days prior to the first dose of the study treatment; 7. patients who have received \>30 gy of radical radiotherapy within 28 days before the first dose of study treatment; 8. unresolved ctcae grade \>1 toxicity attributed to any prior anti-tumor therapy; 9. use of live attenuated vaccines within 28 days before the first dose of the study treatment; 10. patients who have received any systemic immunosuppressants within 14 days prior to the first dose of study treatment; 11. patients with interstitial pneumonitis or interstitial lung disease; past history of interstitial pneumonitis or interstitial lung disease requiring hormone therapy; 12. history of autoimmune diseases; 13. history of clinically significant bleeding symptom or bleeding tendency within 3 months before the first dose of study treatment; 14. history of clinically significant cardiovascular or cerebrovascular diseases within 6 months prior to the first dose of study treatment; 15. evidence or history of arterial/venous thrombosis within 3 months before the first dose; 16. prior malignancy (other than current malignant tumor) within 5 ears before the first dose of study treatment; 17. known history of serious allergic reactions to the investigational product or its main ingredients; 18. history of immunodeficiency; 19. presence of active hepatitis b or active hepatitis c; 20. severe infections within 4 weeks prior to the first study treatment; 21. evidence or history of active pulmonary tuberculosis within 1 year before study entry; 22. any other conditions that are not suitable for participation in the study in the investigator's opinion.